1 Basic details about project

1.1 Abbreviations

IC = intermittent claudication
RP = rest pain
TL = tissue loss
TASCII/TASC-II/TASC = Trans-Atlantic Inter-Society Consensus-II
Bal = Balloon angioplasty
DEB = Drug-eluting balloon
St = Stent
Sup = Supera
VIA = VIABAHN
Fail = Failed procedure
CFA = common femoral artery
P3 = P3 segment of popliteal artery
Lysis = intra-arterial thrombolysis
Tech succ = technical success
Complex no. = number of complexity markers

1.2 Inclusion and exclusion criteria

Indication criteria are:
- Endovascular intervention to femoro-popliteal (fem-pop) segment
- Intermittent claudication, rest pain and tissue loss
Exclusion criteria are:
- Femoro-popliteal bypass graft on ipsilateral leg
- Acute limb ischaemia or other indication not listed above
- Previous intervention to same limb is NOT an exclusion criterion

1.3 Period covered

Procedures from 2016-01-11 to 2020-04-01 are included here

2 Patient information

2.1 Patients per year

505 are included
They are spread across the years as demonstrated:

2.2 Age per year

Mean age of patients is 70.3 years
Median age of patients is 72 years
Age is demonstrated in this boxplot:

Age variation by year is demonstrated in this boxplot:

To check if age is evenly distributed across the years, they can be plotted to identify outliers:

Data points 164, 396 and 431 are outliers
Point 164: 37 years old (2017)
Point 396: 35 years old (2019)
Point 431: 32 years old (2019)
Welch’s one-way test performed instead of ANOVA due to inhomogeneity of variances, looking for a significant age difference between years:

##
##  One-way analysis of means (not assuming equal variances)
##
## data:  patients$Age and as.factor(patients$Year)
## F = 0.56858, num df = 4.00, denom df = 196.13, p-value = 0.6857

2.3 Age per indication

Average age by indication for intervention is as shown here:

Indication	Mean age	Median age
IC	64.0	65.0
RP	70.2	71.5
TL	71.9	72.0

These data are demonstrated in this boxplot:

To check if these data are evenly distributed, they can be plotted to identify outliers:

Data points 396, 431 and 488 are outliers
Point 396: 35 years old (TL)
Point 431: 32 years old (TL)
Point 164: 39 years old (RP)
Welch’s one-way test performed instead of ANOVA due to inhomogeneity of variances:

##
##  One-way analysis of means (not assuming equal variances)
##
## data:  patients$Age and patients$Indication
## F = 23.969, num df = 2.00, denom df = 151.89, p-value = 8.972e-10

Pairwise t-test with no assumption of equal variances to look for where differences in means are, given that Welch’s test was signficant:

##
##  Pairwise comparisons using t tests with non-pooled SD
##
## data:  patients$Age and patients$Indication
##
##    IC      RP
## RP 0.00057 -
## TL 3.1e-10 0.27292
##
## P value adjustment method: BH

2.4 Age per gender

Average age by gender for intervention is as shown here:

Gender	Mean age	Median age
Man	72.4	74
Woman	68.9	70

These data are demonstrated in this boxplot:

t-test test to look for differences between mean ages:

##
##  Welch Two Sample t-test
##
## data:  patients$Age by patients$Gender
## t = 3.3393, df = 378.17, p-value = 0.0009233
## alternative hypothesis: true difference in means is not equal to 0
## 95 percent confidence interval:
##  1.441131 5.568611
## sample estimates:
##   mean in group Man mean in group Woman
##            72.43367            68.92880

3 Limb information

3.1 Limbs per year

551 are included
They are spread across the years as demonstrated:

4 Procedure information

4.1 Procedures per year

622 are included
On average, roughly 149 procedures are performed each year
Or 12 per month
They are spread across the years as demonstrated:

4.2 TASC classification of lesions

These are from the 622 procedures

5 Indication information

Number of procedures performed for each indication are shown here:

Number of procedures each year for each indication are shown here:

5.1 Intermittent claudication

On average, roughly 25 procedures are performed each year for IC
Or 2.1 per month

5.1.1 By TASC

5.1.2 By TASC each year

5.2 Rest pain

## estimate only: convert to intervals for accuracy
## estimate only: convert to intervals for accuracy

On average, roughly 22 procedures are performed each year for RP
Or 1.8 per month

5.2.1 By TASC

5.2.2 By TASC each year

5.3 Tissue loss

On average, roughly 103.4 procedures are performed each year for TL
Or 8.5 per month

5.3.1 By TASC

5.3.2 By TASC each year

6 Technical success

6.1 Overall technical success

91% of all fem-pop procedures are technically successful

6.2 Technical success each year

Kruskal-Wallis test to look for difference in success between years:

##
##  Kruskal-Wallis rank sum test
##
## data:  procedures$Successful by as.factor(procedures$Year)
## Kruskal-Wallis chi-squared = 1.0287, df = 4, p-value = 0.9054

Wilcoxon rank sum test to look for where differences in means are:
(can be ignored if p >= 0.05 for Kruskal-Wallis test)

##
##  Pairwise comparisons using Wilcoxon rank sum test
##
## data:  procedures$Success and as.factor(procedures$Year)
##
##      2016 2017 2018 2019
## 2017 0.97 -    -    -
## 2018 0.97 0.97 -    -
## 2019 0.97 0.97 0.97 -
## 2020 0.97 0.97 0.97 0.97
##
## P value adjustment method: BH

6.3 Technical success by indication

Kruskal-Wallis test to look for difference in success between indications:

##
##  Kruskal-Wallis rank sum test
##
## data:  procedures$Successful by procedures$Indication
## Kruskal-Wallis chi-squared = 0.010751, df = 2, p-value = 0.9946

Wilcoxon rank sum test to look for where differences in means are:
(can be ignored if p >= 0.05 for Kruskal-Wallis test)

##
##  Pairwise comparisons using Wilcoxon rank sum test
##
## data:  procedures$Success and procedures$Indication
##
##    IC   RP
## RP 0.99 -
## TL 0.99 0.99
##
## P value adjustment method: BH

6.4 Technical success by TASC-II

Kruskal-Wallis test to look for difference in success between indications:

##
##  Kruskal-Wallis rank sum test
##
## data:  procedures$Successful by procedures$TASCII
## Kruskal-Wallis chi-squared = 42.006, df = 3, p-value = 4.001e-09

Wilcoxon rank sum test to look for where differences in means are:
(can be ignored if p >= 0.05 for Kruskal-Wallis test)

##
##  Pairwise comparisons using Wilcoxon rank sum test
##
## data:  procedures$Success and procedures$TASCII
##
##   A       B       C
## B 0.7816  -       -
## C 0.1221  0.0313  -
## D 4.8e-06 1.6e-09 0.0063
##
## P value adjustment method: BH

7 Treatment method

7.1 All procedures

Overall, including failed procedures, 79% of treatments leave nothing behind
More specific devices:

7.2 Device by year

More specific devices:

7.3 Device by indication

The bar chart is separated into three with different y-axes to allow easy comparison of proportions

More specific devices:

7.4 Device by TASC-II

More specific devices:

8 Procedural complexity

Five indicators of increased procedural complexity are recorded, with a binary “yes”/“no” option being available, ie. the success of the added procedural step is not recorded:

‘Iliac’ - iliac angioplasty or stent in the same procedure
‘CFA’ - concurrent common femoral endarterectomy
‘P3’ - P3/below knee segment of the popliteal artery was treated
‘Crural’ - concurrent infra-popliteal angioplasty
‘Lysis’ - acute intra-procedural thrombus requiring intra-arterial thrombolysis

8.1 Number and percentage of individual complexity markers

Yes/No	Iliac	CFA	P3	Crural	Lysis
No	603.0	581.0	505.0	471.0	609.0
Yes	19.0	41.0	117.0	151.0	13.0
% Yes	3.1	6.6	18.8	24.3	2.1

8.2 Number of procedures with total number of complexity markers

Number of complexity markers	Number	Percentage
0	371	59.6
1	168	27.0
2	76	12.2
3	7	1.1

8.2.1 Procedural success by complexity

NB success is defined as successfully treating the fem-pop segment

Kruskal-Wallis test to look for difference in success between complexity levels:

##
##  Kruskal-Wallis rank sum test
##
## data:  procedures$Successful by procedures$multiComp
## Kruskal-Wallis chi-squared = 2.6244, df = 3, p-value = 0.4532

Wilcoxon rank sum test to look for where differences in means are:
(can be ignored if p >= 0.05 for Kruskal-Wallis test)

##
##  Pairwise comparisons using Wilcoxon rank sum test
##
## data:  procedures$Success and procedures$multiComp
##
##   0    1    2
## 1 0.59 -    -
## 2 0.79 0.59 -
## 3 0.59 0.59 0.59
##
## P value adjustment method: BH

9 Survival

Death dates were last checked 17/04/2020
Survival statistics are based on the 505 patients in the data
Kaplan-Meier survival estimator is used for survival curves
Log-rank test is used to sompare survival estimates between groups

9.1 Overall

Kaplan-Meier survival for all patients undergoing fem-pop intervention is plotted below:

9.2 By year

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and Year
##
##      2016 2017 2018 2019
## 2017 0.97 -    -    -
## 2018 0.97 0.95 -    -
## 2019 0.95 0.95 0.95 -
## 2020 0.95 0.95 0.95 0.95
##
## P value adjustment method: BH

9.3 By TASC-II

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and TASCII
##
##   A       B       C
## B 0.00159 -       -
## C 9.3e-05 0.07745 -
## D 0.00013 0.05556 0.36620
##
## P value adjustment method: BH

9.4 By Gender

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and Gender
##
##       Man
## Woman 0.33
##
## P value adjustment method: BH

9.5 By indication

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and Indication
##
##    IC      RP
## RP 5.4e-05 -
## TL 2.1e-09 0.0068
##
## P value adjustment method: BH

9.6 By technical success

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and Successful
##
##     No
## Yes 0.0021
##
## P value adjustment method: BH

9.7 By treatment method

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and Dev
##
##      Bal    St
## St   0.5940 -
## Fail 0.0054 0.0445
##
## P value adjustment method: BH

9.8 By complexity

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and multiComp
##
##   0    1    2
## 1 0.75 -    -
## 2 0.92 0.75 -
## 3 0.75 0.91 0.75
##
## P value adjustment method: BH

9.9 Tissue loss only

9.9.1 By TASC-II

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  tlPat and TASCII
##
##   A     B     C
## B 0.151 -     -
## C 0.039 0.192 -
## D 0.039 0.192 0.600
##
## P value adjustment method: BH

9.9.2 By Gender

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  tlPat and Gender
##
##       Man
## Woman 0.26
##
## P value adjustment method: BH

9.9.3 By technical success

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  tlPat and Successful
##
##     No
## Yes 0.0021
##
## P value adjustment method: BH

9.9.4 By treatment method

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  tlPat and Dev
##
##      Bal    St
## St   0.8884 -
## Fail 0.0064 0.0270
##
## P value adjustment method: BH

9.9.5 By complexity

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  tlPat and multiComp
##
##   0    1    2
## 1 0.61 -    -
## 2 0.51 0.53 -
## 3 0.61 0.61 0.53
##
## P value adjustment method: BH

9.10 30-day survival by indication

Log rank test to look for significant survival difference between groups:

##
##  Pairwise comparisons using Log-Rank test
##
## data:  patients and Indication
##
##    IC    RP
## RP 1.000 -
## TL 0.086 0.086
##
## P value adjustment method: BH

Angioplasty and stenting in the femoro-popliteal segment

Martin Hennessy, Keith Hussey

05/04/2020

1 Basic details about project

1.1 Abbreviations

1.2 Inclusion and exclusion criteria

1.3 Period covered

2 Patient information

2.1 Patients per year

2.2 Age per year

2.3 Age per indication

2.4 Age per gender

3 Limb information

3.1 Limbs per year

4 Procedure information

4.1 Procedures per year

4.2 TASC classification of lesions

5 Indication information

5.1 Intermittent claudication

5.1.1 By TASC

5.1.2 By TASC each year

5.2 Rest pain

5.2.1 By TASC

5.2.2 By TASC each year

5.3 Tissue loss

5.3.1 By TASC

5.3.2 By TASC each year

6 Technical success

6.1 Overall technical success

6.2 Technical success each year

6.3 Technical success by indication

6.4 Technical success by TASC-II

7 Treatment method

7.1 All procedures

7.2 Device by year

7.3 Device by indication

7.4 Device by TASC-II

8 Procedural complexity

8.1 Number and percentage of individual complexity markers

8.2 Number of procedures with total number of complexity markers

8.2.1 Procedural success by complexity

9 Survival

9.1 Overall

9.2 By year

9.3 By TASC-II

9.4 By Gender

9.5 By indication

9.6 By technical success

9.7 By treatment method

9.8 By complexity

9.9 Tissue loss only

9.9.1 By TASC-II

9.9.2 By Gender

9.9.3 By technical success

9.9.4 By treatment method

9.9.5 By complexity

9.10 30-day survival by indication